A phase II trial examining the safety and preliminary efficacy of repetitive transcranial magnetic stimulation (rTMS) for people living with multiple sclerosis

None listed

We are looking for 108 people with multiple sclerosis (MS) in Australia to measure the effects of transcranial magnetic stimulation (TMS for short) on MS. TMS can non-invasively and painlessly activate nerve cells in the human brain and can be used to change nerve cell activity. MBS is currently used to treat depression but has only been used for MS in the research setting. What’s involved: A total of 23 visits over the study duration of 4 to 5 months. 1. A full medical history, physical examination, and extended disability status score (EDSS). This will take about 30 minutes. 2. You will be randomly assigned to a treatment group, and will have a 67% chance of being in the MBS group and 33% chance of being in the placebo group. The placebo is a fake MBS, it looks and feels like the real thing, with no brain stimulation. You will not know which group you are in until the study is completed. 3. Daily MBS or placebo sessions (Mon-Fri) for 4 to 5 weeks, at a time convenient to you. A total of 20 sessions, each one takes about 15 minutes. We will monitor side effects, new symptoms and changes in your medications. You can continue taking your current medications whilst in this study but must tell us about any changes, any GP, hospital or emergency visits, any COVID-19 symptoms or tests. 4. Magnetic Resonance Imaging (MRI) before and after your 20 MBS or placebo sessions. Each MRI takes about an hour. 5. A series of questionnaires before and after your 20 MBS or placebo sessions. You will repeat these again online after 3 months. Questionnaires take about 30 minutes to complete and include. a. hospital anxiety and depression score (HADS), 14 questions b. quality of life assessment (AQoL-8D), 35 questions c. fatigue severity scale (FSS), 9 questions d. sleep quality assessment (PQSI & NRS), 7 questions 6. MS Functional tests: Timed 25-foot walking test (T25-FW), Symbol Digit Modality Test (SDMT) and 9 Hole Peg Test (9HPT) before, during and after your MBS or placebo sessions. You will complete 3 practice sessions before starting the trial. These tests will assess arm and leg mobility as well as brain function and processing speed. The three tests take about 30 minutes to complete. You can use a walking stick or aid during the walking test. The aims of the study are; 1. To determine whether magnetic brain stimulation improves the MS functional composite score for people living with MS. 2. To determine if magnetic brain stimulation; - is safe & tolerable in people with MS. - improves quality of life in people with MS. - reduces anxiety and depression in people with MS. - reduces fatigue in people with MS. - improves sleep quality in people with MS 3. To determine if magnetic brain stimulation can effectively promote remyelination in people with MS, and if remyelination correlates with improvements in functional or patient reported outcomes.